Financial Performance - INGREZZA net product sales reached $2.3 billion in 2024, $1.8 billion in 2023, and $1.4 billion in 2022, accounting for substantially all total net product sales during these years [18]. - Four customers accounted for approximately 93% of total product sales for 2024 and about 98% of accounts receivable as of December 31, 2024 [160]. - The commercial success of INGREZZA and CRENESSITY will significantly impact future revenues and profitability [163]. - The company anticipates fluctuations in operating results due to various factors, including seasonality and timing of customer purchases [173]. - The company expects to increase expenses and investments in the coming years to fund operations and capital expenditures [166]. - The company may need to raise additional capital to fund its business plan and future research, development, and commercial efforts [161]. - The company anticipates increased expenses in the foreseeable future, which may challenge its ability to sustain growth and profitability [130]. Market and Competition - Approximately 800,000 people in the U.S. are estimated to be affected by tardive dyskinesia, with 90% of the 40,000 individuals with Huntington's disease expected to develop chorea, and CAH affecting around 30,000 people in the U.S. [18]. - Competition for INGREZZA includes AUSTEDO, which introduced once-daily dosing in February 2023, and various off-label treatments [50]. - CRENESSITY competes with high-dose corticosteroid monotherapy, the current standard of care for CAH, with over two dozen companies manufacturing steroid-based products in the U.S. [50]. - The ongoing Journey study evaluates valbenazine for schizophrenia, a condition affecting over 20 million people globally, with annual costs exceeding $150 billion in the U.S. [28]. - The commercial success of INGREZZA and CRENESSITY is contingent upon their acceptance as safe and effective by the medical community and patients [119]. - The company faces intense competition from other pharmaceutical and biotechnology firms, which may impact the demand for its products [120]. Regulatory Environment - The FDA has a goal of 10 months to review standard NDAs for new molecular entities, with a six-month goal for priority NDAs [62]. - The FDA may require risk evaluation and mitigation strategies before approving a new drug application, which can affect market potential [69]. - Orphan drug designation may be granted for drugs treating rare diseases, but does not shorten the regulatory review process [71]. - Regulatory approval processes vary by country, and foreign approvals may not be granted timely or at all, impacting market entry [70]. - The FDA grants a seven-year marketing exclusivity for approved orphan drugs, preventing approval of similar drugs unless clinically superior [72]. - Post-approval requirements include ongoing FDA regulation, recordkeeping, and potential Phase 4 clinical trials to monitor safety and effectiveness [74]. - The company is subject to comprehensive regulatory oversight by the EMA, the European Commission, and/or the competent regulatory authorities of the individual EU Member States [103]. - The company must comply with a range of regulatory requirements applicable to the manufacturing, marketing, promotion, and sale of medicinal products [103]. Research and Development - The Phase 2 SAVITRI™ study of osavampator demonstrated a statistically significant change in the MADRS total score at Day 28 (p=0.0159) and Day 56 (p=0.0016) [30]. - NBI-1117568 showed a statistically significant reduction in PANSS total score at Week 6 (p=0.011) in a Phase 2 clinical study for schizophrenia [33]. - NBI-1070770 is in Phase 2 studies as a potential treatment for major depressive disorder, with ongoing evaluations of its efficacy and safety [35]. - The company has a diversified pipeline with multiple compounds in mid- to late-phase development across core therapeutic areas, including neuropsychiatry and neurology [17]. - The company is transforming its research and development strategies to include biologics, which requires substantial investment [115]. - The company has made substantial investments in R&D personnel and facilities to support its expansion into biologics, indicating a strategic shift in its product development focus [145]. Intellectual Property - INGREZZA is covered by 22 U.S. patents expiring between 2027 and 2040, with a patent term extension for U.S. Patent No. 8,039,627 now expiring in 2031 [44]. - Settlement agreements allow generic versions of INGREZZA to be sold in the U.S. starting March 1, 2038, or earlier under certain conditions [44]. - CRENESSITY is covered by U.S. patents expiring between 2035 and 2041, with potential extensions allowing expiration as late as 2045 [44]. - The company emphasizes the importance of obtaining patent protection for its proprietary technology and compounds to maintain competitive advantage [191]. - The company faces risks related to the validity and enforceability of its patents, which may be challenged by third parties [193]. Employee and Organizational Growth - The company has grown to a team of approximately 1,800 employees as of December 31, 2024, adding more than 400 new employees during 2024 [108]. - The company expects to add additional employees in 2025, focusing on expanding its research and development organization [109]. - The company has grown its full-time employee count from approximately 200 in 2017 to 1,800 as of December 31, 2024, indicating significant organizational expansion [142]. - The leadership transition with the retirement of the former CEO and the appointment of a new CEO may impact investor confidence and operational stability [148]. Legislative and Policy Risks - The Inflation Reduction Act of 2022 allows for price negotiations on high-expenditure drugs, which may impact competitive pressure on products like INGREZZA [84]. - The Medicare drug negotiation program may affect pricing for drugs like AUSTEDO and AUSTEDO XR, potentially impacting INGREZZA revenues [85]. - Legislative changes may lead to more rigorous coverage criteria and lower reimbursement rates for prescription drugs [88]. - The company is unable to predict future legislative impacts on the healthcare industry and its business [92]. - The company is evaluating the potential impact of new healthcare reforms and drug pricing measures, which could adversely affect its business and financial condition [183]. Cybersecurity Risks - Cybersecurity threats pose risks to the company's information technology systems and sensitive data [204]. - The complexity of the company's IT systems makes them vulnerable to various evolving threats, including cyber-attacks [205]. - The company must navigate a landscape of increasing cyber threats, which could disrupt operations and clinical trials [206]. - Ransomware attacks are increasingly prevalent, potentially leading to significant operational interruptions and loss of sensitive data [207]. - Supply chain attacks have risen in frequency and severity, posing risks to information technology systems and infrastructure [213]. - Remote work has heightened risks to information technology systems, as employees utilize external network connections and devices [208]. - The company has not experienced a material security incident to date, but cybersecurity threats are expected to continue [214]. - Security incidents could lead to material adverse consequences, including financial loss and reputational harm [215].

Group 1 - Neurocrine Biosciences reported fourth-quarter adjusted EPS of $1.69, exceeding last year's $1.54 and beating the consensus of $1.56 [1] - The company reported sales of $627.7 million, up from $515.2 million a year ago, but missed the consensus of $628.99 million [1] - Ingrezza's fourth-quarter net product sales were $615 million, reflecting a 23% growth compared to the fourth quarter of 2023, driven by strong patient demand [2] Group 2 - Crenessity's fourth-quarter net product sales were $2 million, following initial pharmacy orders after FDA approval in December 2024 [2] - Neurocrine expects Ingrezza net product sales for 2025 to be between $2.5 billion and $2.6 billion [2] - William Blair views Ingrezza's 2025 revenue guidance as slightly conservative compared to their estimate of $2.60 billion and the Street estimate of $2.67 billion [3] Group 3 - Analyst Myles Minter considers Ingrezza the gold-standard pharmacotherapy for tardive dyskinesia due to its dosing convenience and lack of severe FDA warnings [4] - Ingrezza has 14 years of potential patent protection, indicating a long growth trajectory despite near-term competitive pressures [5] - Neurocrine's stock price decreased by 1.91% to $121.98, with various analysts maintaining or adjusting their ratings and price targets [5]

Neurocrine Biosciences exceeded earnings expectations for Q4 2024, driven by robust sales from key product Ingrezza, while revenue slightly missed estimates.Neurological therapeutics specialist Neurocrine Biosciences (NBIX -0.46%) reported mixed fourth-quarter earnings on Thursday, Feb. 6. Despite a slight miss on revenue expectations, its adjusted earnings per share (EPS) beat estimates significantly. Overall, the quarter showcased strong performance, particularly from the flagship prescription medication ...

Financial Data and Key Metrics Changes - Neurocrine reported record sales growth for INGREZZA in 2024, increasing annual sales by approximately $475 million, driven by increased volume and improved gross-to-net dynamics [22] - The guidance for INGREZZA sales in 2025 is projected to be between $2.5 billion and $2.6 billion, reflecting a growth of $250 million at the midpoint [14][24] - The company anticipates a slower growth trajectory for INGREZZA due to increased competitive pressure and utilization management by payers [14][24] Business Line Data and Key Metrics Changes - INGREZZA continues to show strong performance with expectations of double-digit year-over-year growth, although moderated compared to 2024 [7][14] - Quinicity, the newly launched treatment for congenital adrenal hyperplasia, is expected to have measured early revenues due to factors such as delayed reimbursement and patient flow [16][27] - The sales organization has been expanded to better address the needs of the approximately 90% of untreated tardive dyskinesia patients in the US [9][24] Market Data and Key Metrics Changes - The market for tardive dyskinesia is estimated to have around 800,000 patients in the US, with less than 10% currently treated with VMAT2 inhibitors, indicating substantial growth potential [22][24] - The competitive landscape is evolving, with increased utilization management impacting access to INGREZZA [80][82] Company Strategy and Development Direction - Neurocrine aims to diversify its revenue profile with Quinicity and anticipates it could become a second blockbuster therapy [10][21] - The company plans to enhance its R&D productivity, expecting to launch a new commercial product every two years at steady state [11] - The focus will be on expanding into new therapeutic areas and advancing biologics, with a robust neuroscience pipeline expected to grow from 12 to 18 programs by year-end [11][37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential of INGREZZA despite current headwinds, emphasizing the unmet medical need in the tardive dyskinesia market [14][56] - The early feedback from the CAH community regarding Quinicity has been positive, with expectations for broad reimbursement in the future [75] - Management acknowledged the challenges of launching a new treatment but remains optimistic about Quinicity's potential to transform care for CAH patients [10][28] Other Important Information - The company is investing in both revenue growth and R&D programs, with a significant focus on the launch of Quinicity and the expanded INGREZZA sales force [18][19] - The anticipated increase in operating expenses for 2025 aligns with the investment behind the Quinicity launch and sales force expansion [18][19] Q&A Session Summary Question: Expectations for Quinicity launch revenue trajectory - Management indicated that early launch dynamics for Quinicity are promising, with 11 new patient start forms received shortly after approval, but refrained from providing specific ramp expectations [41][44] Question: Clarification on INGREZZA guidance and market dynamics - Management reiterated that the guidance reflects continued growth despite external factors like payer dynamics and competitive pressures, emphasizing proactive steps to address these challenges [49][52] Question: Insights on payer traction and free drug program for Quinicity - The company has implemented a fast start program to provide free product to patients while reimbursement is secured, with expectations that most patients will require this for one to two months [73][75] Question: Utilization management impact on INGREZZA - Management noted that utilization management has tightened, impacting access, but they are actively working to maximize patient access through a sophisticated infrastructure [80][82] Question: Growth levers among segments for INGREZZA - The greatest growth is expected to come from the psychiatry segment, with ongoing efforts to address telemedicine challenges and high turnover in healthcare providers [85][86] Question: Feedback from end of phase two meetings for osuvamphetor and 568 - Management reported positive feedback and alignment from the agency regarding the registration programs for both osuvamphetor and 568, with support for the planned dose selection [106][107]

Neurocrine Biosciences (NBIX) came out with quarterly earnings of $1 per share, missing the Zacks Consensus Estimate of $1.56 per share. This compares to earnings of $1.44 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -35.90%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $1.47 per share when it actually produced earnings of $1.24, delivering a surprise of -15.65%.Over the last fou ...

Exhibit 99.1 Neurocrine Biosciences Reports Fourth Quarter and Fiscal 2024 Financial Results and Provides Financial Expectations for 2025 INGREZZA (valbenazine) Fourth Quarter and Full Year 2024 Net Product Sales of $615 Million and $2.3 Billion, Representing Year-Over-Year Growth of 23% and 26% Respectively ® • INGREZZA fourth quarter and fiscal 2024 net product sales were $615 million and $2.3 billion, respectively • INGREZZA fourth quarter net product sales grew 23% compared to fourth quarter 2023, drive ...

INGREZZA® (valbenazine) Fourth Quarter and Full Year 2024 Net Product Sales of $615 Million and $2.3 Billion, Representing Year-Over-Year Growth of 23% and 26% Respectively INGREZZA® (valbenazine) Full Year 2025 Net Product Sales Guidance of $2.5 - $2.6 Billion CRENESSITYTM (crinecerfont), a First-in-Class Treatment for Children and Adults with Classic Congenital Adrenal Hyperplasia, Approved and Launched in the United States Phase 3 Programs for Osavampator in Major Depressive Disorder and NBI-'568 in Schi ...

The upcoming report from Neurocrine Biosciences (NBIX) is expected to reveal quarterly earnings of $1.58 per share, indicating an increase of 9.7% compared to the year-ago period. Analysts forecast revenues of $630.72 million, representing an increase of 22.4% year over year.The current level reflects a downward revision of 9.4% in the consensus EPS estimate for the quarter over the past 30 days. This demonstrates how the analysts covering the stock have collectively reappraised their initial projections ov ...

Brendan, a Pennsylvanian by birth:-Completed a Ph.D. at Stanford University in the field of organic synthesis (2009). -Worked for a major pharmaceutical company (Merck, 2009-2013).-Worked in biotech including start-ups (Theravance/Aspira) prior to securing employment at Caltech.-First employee and co-founder of 1200 Pharma as it spun out of Caltech garnering major investment (into the 8 figures).-Remains an avid investor, focused on market trends and especially biotechnology stocks.Analyst’s Disclosure: I/w ...

Conference Call and Webcast Scheduled for Thursday, February 6SAN DIEGO, Jan. 30, 2025 /PRNewswire/ --Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that it has scheduled its fourth quarter and year-end 2024 financial results conference call and webcast for 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time) on February 6, 2025.The schedule for the press release and conference call / webcast is as follows: Q4 & Year-End 2024 Press Release: February 6, 2025 at 1:00 p.m. PT / 4:00 p.m. ET Q4 & Year-E ...